Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Obesity and type 2 Diabetes Mellitus prevalence has doubled in the last 30 years and nearly one fifth of UAE population has Type 2 Diabetes while more than quarter has obesity.

Non-alcoholic fatty liver disease is present in more than 30% of patients with type 2 diabetes and in > 50% patient with obesity

20% of patients with Non-alcoholic fatty liver disease progress to develop non-alcoholic steatohepatitis which can lead to liver failure and hepatocellular carcinoma.

This study aims to use GLP-1 analogue to see effects on liver fat deposition after six months of treatment

There is no current randomised study on treatment of non-alcoholic steatohepatitis in United Arab Emirates population; so once completed this will the first study.

This study will pave the way for developing a treatment pathway for patients with non-alcoholic fatty liver disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Adnan Agha

Criteria

Inclusion Criteria:

• Age > 18; either male or female

• Diagnosed to have Type 2 Diabetes Mellitus for > 1 year.

• Presence of NAFLD advanced fibrosis (F3 and F4; defined by NFS of > 0.676)

• Able to consent independently

• Not already on GLP-1 analogues or SGLT2 inhibitors or pioglitazone

• Good general health

• BMI> 19 but less than 40

Exclusion Criteria:

• Known history of alcohol excess or current alcohol use of > 20 g/week

• Evidence of pre-existing liver or biliary disease (hepatoma, biliary tract obstruction; liver cirrhosis secondary to viral infection or immune/ congenital).

• Known or suspected hypersensitivity to GLP-1 analogues or pioglitazone.

• Receipt of any investigational medicinal product within 30 days before screening.

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.

• Endocrinopathies (e.g., Cushing syndrome)

• Personal history of heart disease especially heart failure

• History of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

• eGFR < 30

• history of heamturia or bladder cancer

• history of osteoporosis

• ALT ≥3.5 times the upper normal limit (UNL)

• Taking steroids, antipsychotics or progesterone preparations

• Uncontrolled hypertension

• Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.

• HbA1c > 10%

• Claustrophobia or unable to get MRI due to contraindications (e.g metal in the body)

• Weight > 150 kg (due to imaging trolley restrictions)